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Trial Purpose

This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

View more trial information on ClinicalTrials.gov
National Trial Reference NumberNational Trial Reference NumberA unique identification code given to each clinical trial record registered on ClinicalTrials.gov. Also called the ClinicalTrials.gov identifier. NCT04924075

MSD Protocol ID

MK-6482-015

Conditions

Advanced Gastrointestinal Stromal Tumor, HIF-2α Mutated Cancers, Pancreatic Neuroendocrine Tumor, Pheochromocytoma/Paraganglioma, Von Hippel-Lindau Disease

Age Range

12+
SexSexSex assigned at birth. Sex is distinct from gender-based eligibility. ALL
Trial PhaseTrial PhaseThe stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the trial’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions. 2

Start Date

End Date

2021-08-12

2029-12-27

Study Details

Patient Participation

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial.

Conditions

Advanced Gastrointestinal Stromal Tumor, HIF-2α Mutated Cancers, Pancreatic Neuroendocrine Tumor, Pheochromocytoma/Paraganglioma, Von Hippel-Lindau Disease

Trial Phase 2

In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial Locations

Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

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Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational medicine that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read our “What to Consider” page for more questions to ask and think about

Clinicaltrials.gov Identifier

NCT04924075

EudraCT Number

2020-005028-13

When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.

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